Part 1. Overview Information

Key Dates

No late applications will be accepted for this Notice of Funding Opportunity.

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Purpose

The goal of this notice of funding opportunity announcement (NOFO) is to advance the field of NICHD-relevant population dynamics research by providing infrastructure that will increase research impact, innovation, and productivity; support the development of junior scientists; and maximize the efficiency of research support.

Objectives

The objectives of this initiative are to:

• Increase the scientific impact, innovation, and productivity of population dynamics research;
• Increase competitiveness for peer-reviewed external funding in population dynamics research;
• Support experiences for junior population dynamics scientists that will contribute to their research independence; and
• Maximize the efficiency of funding for population dynamics research by minimizing the financial and time burdens of providing administrative and other research support services associated with research projects.

Scope

This initiative will provide funding for infrastructure cores to support population dynamics research at already productive population dynamics research centers. Applicant centers are expected to have a recent record of high impact, innovative scientific publications and competitiveness for peer-reviewed external funding for research within the scientific mission of the NICHD Population Dynamics Branch (PDB)

Cores

Applications must include a minimum of two research infrastructure cores: a mandatory Administrative Core plus a Development Core and/or one or more Scientific/Technical Cores. A Development Core should support activities to develop junior-level center affiliates and advance new scientific research within the center. A Scientific/Technical Core is meant to provide scientific and technical services and resources to center affiliates to enhance their research capabilities.

With the exception of the Development Core, which should focus on new projects, the cores should provide support for both existing projects and the development of new projects. The proposed cores should be effective in promoting scientific impact, innovation, productivity, and competitiveness, but need not be innovative themselves. This NOFO encourages core activities promoting interdisciplinary collaborations and collaborations within and across institutions.

Enhancing Research Community Access to Shared Resources

The NICHD Strategic Plan 2020 recognizes the importance of research resources and infrastructure that help investigators advance fundamental knowledge. Appropriate scientific stewardship includes promoting an inclusive workforce, providing access to data and related resources, and collaborating outside one's own organization.

This initiative also encourages these Strategic Plan goals for population dynamics research centers. Applicants must incorporate innovative approaches for access to P2C resources by population scientists with primary permanent appointments at institutions that are not award recipients through the NICHD Population Dynamics Centers Research Infrastructure Program (PDRIP). Plans for enhancing research community access will be part of each proposed Core. Examples of such activities may include facilitating the use of Research Data Centers (RDCs) or other scientific/technical resources; sharing bootcamps or working groups; hosting scholarly visits or scholars-in-residence; or providing mentors to population scientists outside the home institution. This list is only exemplary; other activities may fulfill this component of enhancing access by those outside the applicant organization. Proposed activities must be tied to specific programmatic activities within each Core for which NICHD funding is requested.

Population scientists from organizations that are not PDRIP awardees may be incorporated as individuals or collaborations may be developed at the institutional level. The selection process for outside affiliates should be based on the potential for impact on the field.

History, size, and institutional context of centers

This initiative invites applications from both recently founded and long-established population dynamics research centers. This initiative is not limited to population dynamics research centers that have received previous funding from the PDRIP. Funds issued through this initiative are meant to foster scientific impact, innovation, productivity, and competitiveness for peer-reviewed external funding for research within the scientific mission of PDB in the next five-year project period, not only as a reward for past performance. Competitiveness for external funding includes external funding for research within the PDB scientific mission from all sources, not solely funding from PDB. This initiative invites applications from population research centers of any size, from small to large. A center's productivity, impact, and innovation will be assessed relative to the number of center scientists; a highly productive small center may have greater impact than a moderately productive medium-sized center, even if the latter has numerically more grants and publications. Because this initiative is expected to enhance competitiveness for funding from NIH and other external sources, the applicant institution is expected to show a strong commitment to the center by providing institutional support to the center.

Resources provided through this initiative are meant to augment existing administrative, scientific, and technical services and resources that are already available to the centers. These resources may not be used to offset or replace research infrastructure already provided by the applicant institution. Access to research infrastructure supported by this NOFO may not be limited to a single research project or research team. Resources provided through this initiative are not meant to be a substitute for research project (e.g., R01, R03, R21), training (e.g., T32, R25), individual fellowship (e.g., F31, F32), conference (e.g., R13), or data archiving (e.g., PAR-22-261: Archiving and Documenting Child Health and Human Development Data Sets (R03 Clinical Trial Not Allowed) (nih.gov)) grant funding. Centers wishing to conduct those types of activities should submit separate applications for support through the appropriate mechanisms.

Specific Areas of Research Interest

To be responsive to this initiative, the Primary Research Areas (PRAs) identified must be within the scientific scope of the NICHD Population Dynamics Branch (PDB). The PDB scientific mission is to support research, research training, and data collection in three areas:

• Demography: The scientific study of human populations, including fertility, pregnancy outcomes, mortality and morbidity (especially maternal, infant, child, adolescent, and young adult mortality and morbidity), migration, population distribution, population stratification (including disparities based on race, ethnicity, sex/gender, and age), nuptiality, family demography, population growth and decline, and the causes and consequences of demographic change;
• Population health: Research on how demographic, social, economic, institutional, geographic, and other factors influence human health, productivity, behavior, and development, with an emphasis on research using population-representative data and natural and policy experiments using methods addressing selection and other sources of bias. Research at multiple levels of analysis, involving interdisciplinary perspectives, incorporating social determinants of health, and elucidating mechanisms leading to health disparities are encouraged.
• Reproductive health: Behavioral and social science research on family planning, infertility, sexually transmitted infections and HIV/AIDS.

The Population Dynamics Branch is a unit within the NICHD and thus encompassed within the NICHD mission. Thus, research on these topics is not responsive to this initiative:

• Research primarily focused on aging and the health and well-being of older people;
• Alzheimer’s disease and AD-related dementias (AD/ADRD);
• Long-term supports and services (LTSS) and Medicare in populations outside the mission of the NICHD;
• Specific organ systems or disease conditions outside the mission of the NICHD; and
• Social and behavioral processes without application to enhancing human health and development or elucidating demographic processes

For the purposes of this initiative, "population dynamics research" and "population research" refer to research within the three responsive areas described above. "Population" is defined as the aggregate collection of individuals in a defined geographic area, social, economic, and/or demographic group. Examples include the residents of New York City, married people in the United States, and African American children under age five. Aggregates defined by their participation in a study, program, or service or by having a diagnosis of a specific medical condition are not considered populations under this definition.

For the purposes of this announcement, the "NICHD Population Dynamics Research Infrastructure Program" refers to all grants and activities supported by RFA-HD-18-013, RFA-HD-19-014, RFA-HD-20-015, RFA-HD-21-010, RFA-HD-22-013 and predecessor and successor announcements.

NICHD Data Sharing Expectations and Requirements

The NIH Policy for Data Management and Sharing (Policy) expects researchers maximize the sharing of scientific data and data be accessible as soon as possible and no later than the time of an associated publication or the end of the award period, whichever comes first. NIH requires all applications submitted in response to this NOFO to include a Data Management and Sharing Plan (Plan). The Plan is expected to address the Elements as described in Supplemental Information to the NIH Policy for Data Management and Sharing: Elements of an NIH Data Management and Sharing Plan (NOT-OD-21-014). The Plan will be reviewed and approved by NIH Program Staff prior to award. Awardees will be required to comply with their approved Plan and any approved updates.

For human data, NICHD/PDB encourages the use of the Data Sharing for Demographic Research (DSDR) archive, a centralized resource for researchers to store and access de-identified data from studies funded by NICHD. Information about DSDR may be obtained at https://www.icpsr.umich.edu/web/pages/DSDR/index.html. For projects generating large-scale human genetic data, applicants should provide a Provisional or Institutional Certification specifying whether the individual-level data can be shared through an NIH approved repository, such as dbGaP and the Sequence Read Archive, in line with the NIH Genomic Data Sharing Policy.

If use of DSDR is not feasible, NICHD/PDB expects awardees to share data through other equivalent broad-sharing data repositories, including NICHD’s DASH. Researchers should submit information about the location and availability of data in other repositories to the DASH Catalog, if applicable.

For applications that aim to co-analyze already shared data with data that have not yet been shared with the broader research community, applicants should describe in their DMS Plans how such primary data will be shared with the broad research community.

Additional information on the Data Management and Sharing Policy is available on the NICHD Office of Data Science and Sharing website.

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Local Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Governments

• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed. 

Applicant organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019. 

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

Other Eligibility Criteria

There are three additional eligibility criteria for applications responding to this NOFO:

Established Research Center. The applicant institution must have an established administrative unit (for example, a center or an institute) that administers or coordinates population dynamics research across the applicant institution, hereafter referred to as the "population research center." Funds from this NOFO must be for this population research center and may not be used to establish a new population research center at the applicant institution. As used in this NOFO, an "established unit" has the following characteristics: the applicant institution has formally created the administrative unit; the unit has an administrative position and reporting structure within the applicant institution; the unit has dedicated space; the unit has a governance and organizational structure; the unit's director has defined responsibilities and authority; and the unit has rules or guidelines for selecting or recruiting members/affiliates. The PD/PI must be the director of the applicant center. Changes in the PD/PI  and Core Leads require prior approval. (See NIH Grants Policy Statement, 8.1.2 Prior Approval Requirements, https://grants.nih.gov/grants/policy/nihgps/html5/section_8/8.1.2_prior_approval_requirements.htm.)

Active Scientists. Applicants must have at least five active scientists working in NICHD-relevant population dynamics research. Active population scientists must hold their primary affiliation with the applicant institution and this position (tenured or non-tenured) must be permanent; trainees, post-doctoral fellows, visiting professors, and scientists with primary appointments at other institutions are excluded. Active population dynamics scientists must meet both of the following criteria:

• Externally-funded population dynamics research grants or contracts within the two most recently completed Federal fiscal years 2021 and 2022; grants awarded in FY 2023 may also be included. Federal fiscal years run from October 1 to September 30; for example, Federal fiscal year 2022 runs from October 1, 2021 to September 30, 2022. The designated active scientist must be the PD/PI, a Multiple Program Director/Principal Investigator (MPD/MPI), or Key/Senior Personnel on the qualifying grant or contract and must have received the grant or contract from a source outside the applicant institution. The Project Leads of subprojects on P01 grants also qualify.
• Population dynamics research publications in peer-reviewed journals during the two most recently completed Federal fiscal years; publications from FY 2023 may also be included.

Funding by the NICHD Population Dynamics Branch. Applicants must have at least one active scientist, as defined above, who has received a research grant or other significant funding from the Population Dynamics Branch within Federal fiscal years 2020, 2021, 2022,  or 2023.. Receipt is defined as the issuing of an award for a competing application or annual non-competing renewal; awards in no cost extension status do not count for this purpose. The mechanisms that qualify are research project grants (e.g., R01, R03, R15, R21, R37, R00, U01, UH2/UH3); research program projects (P01); resource-related research project grants (R24, U24); individual career development awards for faculty (K01, K08, K23); institutional training grants (T32); education project grants (R25); and research contracts (N01, N02, N03, N44, Y01, Y02, Y03) that were funded or administered by the Population Dynamics Branch. Mechanisms that do not qualify are individual pre-doctoral and post-doctoral fellowships (e.g., F30, F31, F32, K99), conference grants (e.g., R13, U13), and P2C grants funded through this Population Dynamics Centers Research Infrastructure program. Grants considered to be funded or administered by the Population Dynamics Branch have a grant number that includes the Institute/Center designation of "HD" and a program official who is a member of the Population Dynamics Branch staff.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

Only one application per institution (normally identified by having a unique entity identifier (UEI) number or NIH IPF number) is allowed.

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Institutions may not hold more than one NICHD Population Dynamics Centers Research Infrastructure Program P2C award at a time. For example, institutions who received competing awards from RFA-HD-20-015, RFA-HD-21-010, or RFA-HD-22-013 are not eligible to apply. This prohibition precludes the submission of applications to this program from institutions with existing awards that will not complete their current competitive period within this fiscal year. Applications from such institutions will not be accepted for review.

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this NOFO. See the administrative office for instructions if planning to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed in this notice of funding opportunity to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Rebecca Clark, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-496-1175
Email: rclark@mail.nih.gov 

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing a multi-component application.

The application should consist of the following components:

• Overall: required
• Administrative Core: required; minimum 1, maximum 1
•  
• At least one of the following:
  • Development Core: Optional; minimum 0, maximum 1
  • Scientific-Technical Core:  Optional; minimum 0, maximum 3

Overall Component

When preparing the application, use Component Type ‘Overall’.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424(R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement (Overall)

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Research & Related Other Project Information (Overall)

Follow standard instructions.

Facilities & Other Resources: Explain the center's administrative position within the larger institution, including formal academic departments and other scientifically related centers. Explain how the scientific and institutional environments at the applicant institution contribute to the probability of success for achieving the Specific Aims described in this application. Describe the organizational resources available to the center. Identify the facilities to be used, including dedicated space, computer facilities and resources, laboratories, and other facilities. If appropriate, indicate their capacities, pertinent capabilities, relative proximity, and extent of availability to the project. Relative proximity of resources and size and shape of dedicated space may be presented in either graphic or narrative form. Describe only those resources that are directly related to achieving the Specific Aims described in this application or that complement the proposed research support cores. Provide any information describing the Other Resources available to the project (e.g., secure data room) and the extent to which they would be available to the project.

Describe institutional investment in the success of the center's Early Stage Investigators (ESI), e.g., resources for classes, travel, and training; collegial support such as career enrichment programs, assistance and guidance in the supervision of trainees involved with the ESI's projects, and availability of organized peer groups; logistical support such as administrative management and oversight and best practices training; and financial support such as protected time for research with salary support and coverage of supplies, equipment and technical personnel.

List types and amount of committed funding the center receives from the applicant institution. Examples include but are not limited to dedicated equipment, dedicated space, salary support for investigators or core staff, faculty appointments in subject areas relevant to the goals of the program, operating budgets, financial support for new space or equipment, and arrangements the center has to recover indirect costs. Include salaries only if the support is provided for a center-related function such as directing a center, managing a core, or similar activities. Institutional support for center and core personnel and research faculty should be reflected in the budget request, so the effort proposed may exceed the budget request to NICHD. This information may be presented in tabular form.

Other attachments: Include an attachment titled Active Research Support. The information presented in this section constitutes the center's "externally funded annual support for population dynamics research and training" (see Award Budget in Section II).

Provide information about the center's external funding for population dynamics research, research training, and data collection that is within the mission of PDB and was received in either FY 2021 or FY 2022; select one fiscal year, do not present information for both. This information may be presented in tabular form. (Comparable grants awarded in FY 2023 may be listed in a separate supplemental table.) Report only direct costs; do not report total costs. Report only on funding for activities that are within the scope of PDB within the mission of the NICHD; do not report all funding to all center affiliates.

List the following:

• NICHD Population Dynamics Research Infrastructure Program funding.
• Funding that the center received directly from PDB for which the applicant institution is the grantee and the PD/PI(s) has an appointment at the applicant institution.
• Subcontracts that the center received indirectly from PDB, via PDB grants made to other institutions.
• Funding that the center received directly from National Institutes of Health (NIH) but not from PDB. Because most NIH grant applications that address scientific areas within the scope of PDB are assigned to PDB, it is expected that the list of grants from other NIH sources should not be extensive. Grants with a secondary assignment to NICHD linked to a program official who is a member of the Population Dynamics Branch staff are included here, noting the existence of the secondary assignment. If a grant does not have primary or secondary assignment to PDB, the applicant must explain how the grant relates to the PDB scope within the NICHD mission. Such funding must be responsive to this initiative per Part II, Section 1.
• Subcontracts that the center received indirectly from NIH, but not PDB, via NIH grants made to other institutions. Because most NIH grant applications that address scientific areas within the scope of PDB are assigned to PDB, it is expected that the list of grants from other NIH sources should not be extensive. Subcontracts to grants with a secondary assignment to NICHD linked to a program official who is a member of the Population Dynamics Branch staff are included here, noting the existence of the secondary assignment. If no secondary assignment exists, the applicant must explain how the grant fits in the PDB scope within the NICHD mission. Such funding must be responsive to this initiative per Part II, Section 1.
• Funding that the center received directly from non-NIH sources. Do not include funding unless it is within the scope of PDB within the NICHD mission; explain the relevance of the grant to the PDB scientific mission. Such funding must be responsive to this initiative per Part II, Section 1.
• Subcontracts that the center received indirectly from non-NIH sources. Do not include funding unless it is within the scope of PDB within the NICHD mission; explain the relevance of the grant to the PDB scientific mission. Such funding must be responsive to this initiative per Part II, Section 1.

For all funding, provide the funder and grant/contract number (e.g., NICHD R01HD012345, NIA R03AG543210), the PD/PIs, the grant title, the direct costs for FY 2021 or FY 2022 (or, if a supplemental table is included, FY 2023), and whether the grant is in a no-cost extension. If the center receives no funding in a category, state "None." For multiyear grants, estimate the amount that was spent or received in FY 2021 or FY 2022 (or, if a supplemental table is included, FY 2023). For subcontracts, also provide the grantee institution and the PD/PI of the subcontract at the applicant institution.

Project/Performance Site Locations (Overall)

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Research and Related Senior/Key Person Profile (Overall)

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this NOFO) for the entire application.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

Budget (Overall)

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

PHS 398 Research Plan (Overall)

Introduction to Application: For Resubmission  applications, an Introduction to Application is required in the Overall component.

Specific Aims: The specific aims must address how the center plans to use the funding available through this NOFO to achieve the primary objectives of this initiative. Applicants are required to identify their center's Primary Research Areas (PRAs) to be supported through this program. PRAs are the scientific areas in which the center expects to make its most significant contributions to population dynamics in the next five years. In terms of the first objective—increasing the scientific impact, innovation, and productivity of population dynamics research—centers should focus primarily, but not necessarily entirely, on increasing scientific impact, innovation, and productivity within the center's PRAs. Applicant centers should include metrics to demonstrate that the support they request through this initiative will contribute to the center achieving its specific aims.

Research Strategy: The Research Strategy section includes the Program overview and the Preliminary Studies/Progress Report.

1. Program Overview

The Program Overview should describe the applicant's Specific Aims, including the progress it plans to make in these PRAs, how the applicant plans to achieve these aims, and how the resources provided through this initiative enhance the applicant's ability to achieve these aims, over and above what the applicant would have been able to achieve without the funding from the initiative. Information provided elsewhere in the application—for instance, in the cores, biographical sketches, and Research & Related Other Project Information section—should not be repeated in this section.

• Center affiliates. List the center's affiliates in alphabetical order, indicating whether they are active population dynamics scientists as defined in Other Eligibility Criteria; center affiliates with permanent primary appointments at the applicant institution; center affiliates with either temporary appointments or permanent primary appointments at other institutions; or technical/administrative contributors. Identify one or more active population dynamics scientists with funding from PDB as defined in Other Eligibility Criteria. Other pertinent information, such as discipline (e.g., demography, economics, sociology, public health, anthropology), academic department, or institutional affiliation (for collaborations across institutions) may be included. Information may be presented in tabular form. All individuals affiliated with the applicant center who are expected to significantly contribute to the Specific Aims of this application should be included in this list and should have biographical sketches included in the relevant component of the application. Do not include individuals affiliated with the applicant center who are not expected to contribute to the Specific Aims within the scope of PDB within the NICHD mission.
• Primary Research Areas (PRAs). Describe the research areas in which the center expects to make its most significant contributions to population dynamics in the next five years. It is not expected that all research done at the center will fall within the PRAs, nor is it expected that all active center affiliates will be doing research in these PRAs. Describe the significance and innovation of each PRA. Describe how support from this NOFO will be leveraged to increase the center's ability to make major contributions in the PRAs over and above what could be done without this support. Describe how the experience, training, and ongoing record of accomplishments of the center's leadership and affiliates will contribute to the center's ability to make major contributions in the PRAs. For renewal applications, explain how the PRAs have changed since the prior competing application, if applicable. Information in the core descriptions, biographical sketches, and preliminary studies/progress report may be referenced and must not be repeated.
• Center description. Briefly describe the applicant center's governance and organizational structure, providing an organizational chart; the responsibilities and authority of the Center Director (PD/PI); the role of advisory or user committees, if applicable; membership recruitment or selection; and the privileges, and responsibilities of center membership and how they vary for different levels of membership. Describe how the applicant center defines "junior scientist" for affiliates. Discuss how the institutional context enhances the center's ability to achieve its specific aims. If applicable, discuss circumstances that limit or enhance the applicant institution's ability to provide support. Explain how the center's structure and procedures contribute to advancing the center's PRAs and specific aims.

New applications should not identify or contact potential advisory committee members; renewal applications should identify current advisory committee members. If the center plans to change the Center Director during the project period, explain how the next Center Director will be selected.

Describe how the center assesses the following: the scientific impact and innovation of the research produced by center affiliates; the productivity of center affiliates; the competitiveness for peer-reviewed external funding of affiliates; success in ensuring that junior scientists achieve research independence; and the cost-effectiveness of research infrastructure. Example assessment metrics include, but are not limited to: number of peer-reviewed publications overall, in major demography or social science journals, or in scientific journals with high impact scores; citation counts; number and/or size of grants and/or contracts; number of grant applications submitted; success rates of grant applications submitted; number of new investigator applications submitted and funded; and collection, compilation, and/or dissemination of widely used data sets or other resources. Publications and funding are important metrics of impact, innovation, productivity, and competitiveness, but, for the purposes of this initiative, evidence of the overall scientific impact on the field of population dynamics of a center's recent research is more important than mechanical counts of articles and grants.

2. Preliminary Studies/Progress Report

Applicants who have not received prior support from the PDRIP should include Preliminary Studies related to the center's PRAs and Specific Aims and describe existing research infrastructure activities related to the proposed cores. For renewal applications, include a Progress Report. If applicable, explain how the research emphasis of the center has changed since the prior competing application and why previously supported cores are being dropped or changed. Information provided elsewhere should not be repeated here.

Letters of Support: Include letters of support/agreement for any collaborative/cooperative arrangements, subcontracts, or consultants. For program activities to be conducted off site (i.e., at an institution other than the applicant institution), a letter of assurance or comparable documentation, signed by the collaborator as well as the off-site institutional officials, must be submitted with the application

Resource Sharing Plan:
Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages. If required, the Data Management and Sharing (DMS) Plan must be provided in the Overall component. 

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Overall)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed.

Because pilot projects cannot be described at the time of the application, it is expected that applicants proposing seed grant programs will follow the instructions for delayed onset human subjects research.

PHS Assignment Request Form (Overall)

All instructions in the SF424 (R&R) Application Guide must be followed.

Administrative Core

When preparing your application, use Component Type ‘Admin Core’.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Administrative Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Administrative Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Administrative Core)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Administrative Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Administrative Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Core Lead’ and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Administrative Core)

Budget forms appropriate for the specific component will be included in the application package.

Annual direct costs for the Administrative Core may not exceed $160,000. Applicants should budget funds for at least one PD/PI to attend one annual NICHD Population Dynamics Research Infrastructure Program Principal Investigator meeting. This meeting is usually held in conjunction with the annual meeting of the Population Association of America.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Administrative Core)

For Resubmission applications, an Introduction to Application is allowed for each component.

Specific Aims: Describe the Administrative Core's objectives and the administrative services to be supported through this initiative. 

Research Strategy: The administrative core has two major functions. The first function is overseeing and coordinating the activities funded through the other cores supported through this NOFO. The second function is maximizing the efficiency of funding for population dynamics research by minimizing the financial and time burdens of providing administrative support services associated with research projects. Activities may include aiding in compliance with the administrative and fiscal requirements of funding agencies, managing working paper series and other dissemination of the center's research findings, providing editing services, and managing coordination and communications with other population dynamics centers. The Administrative Core is mandatory.

Provide the following information for the Administrative Core:

• Describe how the support from this NOFO will be used to provide administrative core services over and above the services provided by the applicant institution and center. Describe how the administrative services provided by this NOFO complement and/or leverage administrative services provided by other sources. If administrative services are to be supported both by this NOFO and other sources, describe the financial arrangements. Describe the steps taken to ensure that the core does not duplicate existing activities.
• Explain how the types of administrative services to be provided through support from this NOFO advance the overall application's specific aims.
• Explain how the applicant plans to assess whether the administrative support services supported by this NOFO are advancing the overall application's specific aims. Explain the procedures the applicant is planning to use, and, if applicable, has used, to maximize the efficiency of administrative services supported by this NOFO.
• Explain the procedures the applicant is planning to use to enhance research community access to shared resources through the core and the procedures that will be used to track and evaluate such efforts.
• If applicable, explain why the applicant is continuing, modifying, or dropping administrative activities supported by this NOFO and its predecessors. Information in the progress report may be referenced and should not be repeated here.
• Explain eligibility and priorities for accessing core services supported by this NOFO and the procedures to be used to ensure that junior scientists have access to core services.
• Describe the core's governance and organizational structure.
• If the center plans to change the Core Lead during the project period, explain how the next Core Lead will be selected.

Appendix:

Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Administrative Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

Development Core

When preparing your application, use Component Type 'Development Core.'

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Development Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Development Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Development Core)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Development Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Development Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Core Lead’ and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Development Core)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Development Core)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

Specific Aims: Describe the Development Core's objectives and the current and planned support and services to be provided. The specific aims for the Development Core should explicitly address how the core will increase the scientific impact, innovation, productivity of population dynamics research conducted in the applicant center; increase the center scientists' competitiveness for peer-reviewed external funding in population dynamics research; and support experiences for junior scientists that will contribute to their research independence.

Research Strategy: The research strategy should address how the applicant plans to use support from this NOFO to provide development activities and services above and beyond services and activities provided by the applicant institution and center.

All applicants requesting support for a Development Core must propose a seed grant (or pilot) program supporting small-scale and innovative research projects, especially those that will provide preliminary data leading to larger research efforts in population dynamics research. Seed grant programs may provide funding, but may also, in addition to or instead of, provide other types of support, such as research assistant(s) or dedicated consulting or mentorship. The Development Core may also support other types of development activities, including, but not limited to, application preparation workshops/boot camp; seminar or brown bag series; working groups; and other internal workshops and conferences. Activities to enhance research community access to share resources may include seed grants/pilot projects or may be limited to activities that do not provide funding outside the applicant institution.

Provide the following information for the Development Core:

• Describe how the support from this NOFO will be used to provide development services and activities above and beyond services and activities provided by the applicant institution and center, including those from NIH-funded T, F, K, or R25 programs, if applicable to the applicant center and/or its affiliates. Describe how these services and activities will be provided. Describe how the development services and activities provided by this NOFOcomplement and/or leverage development services and activities provided by other sources. If development services and activities are to be supported both by this NOFO and other sources, describe the financial arrangements. Describe the steps taken to ensure that the core does not duplicate existing activities.
• Explain how the types of development services and activities to be provided through support from this NOFO advance the overall application's specific aims. Explain how the applicant plans to assess whether the development services and activities supported by this NOFO are advancing the overall application's specific aims. Explain the procedures the applicant is planning to use, and, if applicable, has used, to maximize the efficiency of development services and activities supported by this NOFO.
• Explain eligibility and priorities for accessing core services supported by this NOFO and the procedures to be used to ensure that junior scientists have access to core services.
• Describe procedures for soliciting, reviewing, and selecting applications or proposed activities, including who will be involved in the review.
• Explain the procedures the applicant is planning to use to enhance research community access to shared resources through the core and the procedures that will be used to track and evaluate such efforts.
• If applicable, explain why the applicant is continuing, modifying, or dropping development services and activities supported by this NOFO and its predecessors. Information in the progress report may be referenced and should not be repeated here.
• Describe the core's governance and organizational structure.
• If the center plans to change the Core Lead during the project period, explain how the next Core Lead will be selected.

For seed grant programs, address all the items above and, in addition, include the following:

• Procedures for soliciting and reviewing seed grant applications from junior scientists.
• How the core will prioritize the funding of applications from junior scientists.
• Requirements for preparing research applications to continue or expand the research project.
• Size of awards.
• Length of award periods.
• Number of awards permitted to an individual researcher.
• Mentoring arrangements.
• If applicable and not reported elsewhere, the number of applications submitted during the prior competitive segment, the number of awards made, the size of the awards, the number of applications for external funding that arose from seed grants, and the success rate for these applications. Report for the seed grant program overall and for junior scientists.
• For each seed grant, please provide (may be presented in tabular form): name of lead investigator; rank of the lead investigator at the time that the seed grant was initially awarded; and title, recipient organization, and funding outcome of external application(s), if any, that are a direct result of the seed grant.
• Explain the institutional plans and procedures that assure compliance with applicable federal regulations and NIH policies for the protection of human research participants, including the evaluation of risks and protections in project proposals, appropriate ethical oversight of funded projects, and plans for monitoring data and safety in clinical research projects. Information in other sections may be referenced and not repeated.

Renewal applications requesting an increase in funding over the prior competitive award must justify the need for additional funding. This justification should include evidence demonstrating the demand within the center for the new or expanded activity; an explanation of why, if the budget were held at the level of the most recent competitive segment, the new or expanded activities could not be supported through re-budgeting; a discussion of why existing NIH competitive funding mechanisms cannot be used to support the proposed or expanded activity; and a description of the metrics that will be used to assess whether the additional funding has resulted in enhancing the center's ability to achieve the objectives of this NOFO.

Appendix:

Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Development Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed

Delayed Onset Study:

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

Scientific/Technical Core

When preparing your application, use Component Type ‘Sci/Tech Core.’

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Scientific/Technical Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Scientific/Technical Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Scientific/Technical Core)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Scientific/Technical Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Scientific/Technical Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Core Lead’ and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Scientific/Technical Core)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Scientific/Technical Core)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

Specific Aims: Describe the Scientific/Technical Core's objectives and the current and planned support and services to be provided. The specific aims should explicitly address how the core will increase the scientific impact, innovation, and productivity of population dynamics research conducted in the applicant center. Specific aims may also address how the core will increase the center scientists' competitiveness for peer-reviewed external funding in population dynamics research; and how it will support experiences for junior scientists that will contribute to their research independence.

Research Strategy: The research strategy should address how the applicant plans to use support from this NOFO to provide scientific and technical services and resources above and beyond services and activities provided by the applicant institution and center. The services and resources to be provided should be designed to enhance the scientific innovation and technical sophistication of new projects by providing access to advanced scientific/technical expertise at the project development phase and should advance informal scientific education by exposing scientists to advanced methodologies. Examples of the areas for which scientific/technical services and resources may be offered include, but are not limited to, biodemography, support for accessing data and associated documentation, methodology, programming, spatial analysis, and statistical services including personnel and computer time. In order to exploit economies of scale, applicants are strongly urged to consolidate all scientific/technical services and resources under a single core. Applicants proposing more than one Scientific/Technical Core must justify the use of multiple cores by providing evidence that, compared with use of a single core, use of multiple cores will provide cost savings and/or demonstrably better provision of services and resources. Plans for the scientific and technical services and resources to be provided over the project period should reflect any planned innovations in the PRAs.

Provide the following information for the Scientific/Technical Core:

• Describe how the support from this NOFO will be used to provide scientific and technical services and resources above and beyond services and resources provided by the applicant institution and center as well as existing NIH grants (other than a current P2C through the Population Dynamics Branch). Describe how these services and resources will be provided. Describe how the development services and activities provided by this NOFO complement and/or leverage development services and activities provided by other sources. If development services and activities are to be supported both by this NOFO and other sources, describe the financial arrangements. Describe the steps taken to ensure that the core does not duplicate existing activities.
• Explain how the types of scientific and technical services and resources to be provided through support from this NOFO advance the overall application's specific aims. Explain how the applicant plans to assess whether the scientific and technical services and resources supported by this NOFO are advancing the overall application's specific aims. Explain the procedures the applicant is planning to use, and, if applicable, has used, to maximize the efficiency of scientific and technical services and resources supported by this NOFO.
• Explain eligibility and priorities for accessing core services supported by this NOFO and the procedures to be used to ensure that junior scientists have access to core services.
• Explain the procedures the applicant is planning to use to enhance research community access to shared resources through the core and the procedures that will be used to track and evaluate such efforts.
• If applicable, explain why the applicant is continuing, modifying, or dropping scientific and technical services and resources supported by this NOFO and its predecessors. Information in the progress report may be referenced and should not be repeated here.
• Describe the core's governance and organizational structure.
• If the applicant is proposing more than one Scientific/Technical Core, for each Scientific/Technical Core, explain the benefits of having a stand-alone core rather than a single core offering multiple types of services or resources.
• Briefly list the scientific research projects that are expected to use scientific and technical services and resources supported by this NOFO, and, if applicable, the research activities that are currently or recently using services or resources supported by predecessor NOFOs. Information from progress reports, the overall component section, and biographical sketches may be referenced and should not be repeated here.
• If the center plans to change the Core Lead during the project period, explain how the next Core Lead will be selected.

Renewal applications requesting an increase in funding over the prior competitive award must justify the need for additional funding. This justification should include evidence demonstrating the demand within the center for the new or expanded activity; an explanation of why, if the budget were held at the level of the most recent competitive segment, the new or expanded activities could not be supported through re-budgeting; a discussion of why existing NIH competitive funding mechanisms cannot be used to support the proposed or expanded activity; and a description of the metrics that will be used to assess whether the additional funding has resulted in enhancing the center's ability to achieve the objectives of this NOFO.

Appendix:

Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Scientific/Technical Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study:

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed.

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

For information on how applications will be automatically assembled for review and funding consideration after submission, refer to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will not be reviewed.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by NICHD, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Requests of $500,000 or more for direct costs in any year

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the proposed research infrastructure address the needs of the research center that it will administer or coordinate? Is the scope of activities proposed for the research infrastructure appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research center?

For this specific NOFO:

Do the Primary Research Areas (PRAs) proposed in this application address important problems or critical barriers in population dynamics research?

If the overall plans for providing research infrastructure are successful, will scientific knowledge, approaches, and methods of research in population dynamics in this center improve? Will scientific knowledge, approaches, and methods of research in population dynamics beyond this center improve?

Will successful implementation of the overall plans for providing research infrastructure change the application of methods and perspectives of research in population dynamics to new topics with relevance to the scientific understanding of the health and well-being of populations? Will successful implementation of this infrastructure program serve to catalyze methods and perspectives in population dynamics over and above what the applicant could do without this infrastructure support?

Are the targeted individuals or institutions for the plans for enhancing community access to shared resources those for whom this support is likely to have a sustained impact??

Investigator(s)

Are the PD(s)/PI(s) and other personnel well suited to their roles in the infrastructure program? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing population dynamics research? Do the investigators demonstrate significant experience with coordinating collaborative research? If the Center is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach, governance, plans for conflict resolution, and organizational structure appropriate for the infrastructure program? Does the applicant have experience overseeing selection and management of subawards, if needed?

With respect to the proposed PRAs and the scientific field of population dynamics overall, how productive, influential, and competitive for extramural funding are the center affiliates ?

Innovation

Does the application propose novel organizational concepts and management strategies in coordinating population dynamics research in the established research center that the infrastructure program will serve? Are the concepts and strategies novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts and management strategies proposed?

For this specific NOFO:

Does the applicant propose novel approaches for enhancing research community access to P2C resources by population scientists with primary permanent appointments at other institutions?

Approach

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the established research center that the infrastructure will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the infrastructure program, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the infrastructure program is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the infrastructure program? Are an appropriate plan for work-flow and a well-established timeline proposed? Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects?

For this specific NOFO:

Do governance and organizational structure, responsibilities of center leadership and advisors, and the membership policies and practices of this infrastructure program contribute to the likelihood of success?

Are the proposed types of research infrastructure support cores and the methods for providing core services appropriate for advancing the application's overall specific aims and PRAs?

Are proposed activities to enhance research community access to shared resources appropriate and likely to be effective?

Based on the plans presented in this application and, for renewals, past performance, are the proposed types of research infrastructure support cores and the methods for providing core services likely to be cost effective and to increase the impact and innovation of the research done by center scientists and the productivity and competitiveness of center scientists in terms of extramural funding and publications?

For applications that propose supporting pilot projects or seed grants, are there adequate institutional plans and procedures to assure compliance with applicable federal regulations and NIH policies for the protection of human research participants, including the evaluation of risks and protections in project proposals, appropriate ethical oversight of funded projects, and plans for monitoring data and safety in clinical research projects? Are the plans proposed for soliciting, reviewing, and selecting projects to fund appropriate?

For applications that promote interdisciplinary collaborations and collaborations within and across institutions, do the proposed core activities contribute to the likelihood of success?

Environment

Will the institutional environment in which the infrastructure program will operate contribute to the probability of success in facilitating the established research center that it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the infrastructure program proposed? Will the infrastructure program benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?

For this specific NOFO:

Is the level of institutional commitment adequate for the proposed infrastructure activities, taking into account the institutional context? 

Does the academic and physical environment contribute to the likelihood of success through research opportunities, space, equipment, and the potential for interaction with scientists from various departments, institutions or disciplines?

Do the eligibility and priorities for access to infrastructure activities, services, and resources contribute to the likelihood of success?

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animals Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

Revisions

Not applicable.

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

Authentication of Key Biological and/or Chemical Resources:

For [programs/projects/networks/consortia/resources] involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Review Criteria - Administrative Core

Reviewers will evaluate the following items in determining scientific and technical merit. Reviewers will provide a single impact score for the Administrative Core. Reviewers will not give separate scores for the individual items. Reviewers will not provide criterion scores.

• Will the services provided by the core enable the infrastructure program to achieve its specific aims and make advances in the PRAs?
• Do the core director and other core personnel have appropriate qualifications, experience, and commitment? ? Are the core's governance and organizational structure appropriate?
• Is the core cost-effective, and are there appropriate quality control measures? If core functions are, or are to be, supported by both this program and other sources, are the financial arrangements appropriate?
• Are the procedures appropriate for ensuring that junior scientists have adequate access to core services?
• Are the eligibility and priorities for access to core services by population scientists within the applicant institution appropriate?
• Are the eligibility and priorities for access to core services by population scientists in the broader research community outside the applicant institution appropriate?

Review Criteria - Development Core

Reviewers will evaluate the following items in determining scientific and technical merit. Reviewers will provide a single impact score for the Development Core. Reviewers will not give separate scores for the individual items. Reviewers will not provide criterion scores.

• Will the services and activities proposed enhance the applicant's ability to achieve its specific aims and make advances in the PRAs over what could be achieved without these services and activities?
• Are the qualifications, experience, and commitment of the core director and other core personnel appropriate? Are the core's governance and organizational structure appropriate?
• Is the core cost-effective, and are there appropriate quality control measures? If core functions are, or are to be, supported by both this program and other sources, are the financial arrangements appropriate?
• Do the services differ from, enhance, and go beyond development opportunities provided through Ts, Fs, Ks, and R25s, if applicable to the applicant center and/or its affiliates?
• Are procedures for prioritizing the funding of seed grants to junior researchers adequate?
• Are the eligibility and priorities for access to core services by population scientists within the applicant institution appropriate?
• Are the eligibility and priorities for access to core services by population scientists in the broader research community outside the applicant institution appropriate?
• Are procedures for soliciting, reviewing, and selecting applications and proposed activities appropriate?
• For the seed grant program, are the requirements for preparing research applications, size of awards, length of award periods, number of awards permitted to an individual researcher, and mentoring arrangements appropriate? For centers with existing programs, is the success rate for seed grants adequate? Are there adequate institutional plans and procedures to assure compliance with applicable federal regulations and NIH policies for the protection of human research participants, including the evaluation of risks and protections in project proposals, appropriate ethical oversight of funded projects, and plans for monitoring data and safety in clinical research projects?

Review Criteria - Scientific/Technical Core

Reviewers will evaluate the following items in determining scientific and technical merit. Reviewers will provide a single impact score for the Scientific/Technical Core. Reviewers will not give separate scores for the individual bulleted items. Reviewers will not provide criterion scores.

• Will the services and resources proposed enhance the applicant's ability to achieve its specific aims and make advances in the PRAs over what could be achieved without these services and resources?
• If more than one Scientific/Technical Core is proposed, is there adequate justification for proposing each stand-alone core rather than a single core offering multiple types of services or resources?
• Are the qualifications, experience, and commitment of the core director and other core personnel appropriate? Are the core's governance and organizational structure appropriate?
• Is the core cost-effective, and are there appropriate quality control measures? If core functions are, or are to be, supported by both this program and other sources, are the financial arrangements appropriate?
• Are the procedures appropriate for ensuring that junior scientists have adequate access to core services?
• Are the eligibility and priorities for access to core services by population scientists within the applicant institution appropriate?
• Are the eligibility and priorities for access to core services by population scientists in the broader research community outside the applicant institution appropriate?

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by an appropriate Scientific Review Group convened by NICHD, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

Appeals of initial peer review will not be accepted for applications submitted in response to this NOFO

Applications will be assigned to the NICHD. Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Child Health and Human Development (NACHHD) Council. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.
• Program balance.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this NOFO will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

Prior Approval of Pilot Projects

Recipient-selected projects require prior approval by NIH prior to initiation.

• The recipient institution will comply with the NIH Guidance on Changes That Involve Human Subjects in Active Awards and That Will Require Prior NIH Approval.
• The recipient institution will provide NIH with specific plans for data and safety monitoring, and will notify the IRB and NIH of serious adverse events and unanticipated problems, consistent with NIH DSMP policies.

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

• Federal wide Research Terms and Conditions
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS will be required to complete an HHS Assurance of Compliance form (HHS 690) in which the recipient agrees, as a condition of receiving the grant, to administer programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity, The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. See https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html.

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.

•  For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.htmlandhttps://www.lep.gov.

• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including providing program access, reasonable modifications, and to provide effective communication, see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html.

• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.

• For guidance on administering programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.”

Not Applicable

3. Data Management and Sharing

Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.

Consistent with the NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described. If additional Data Management and Sharing requirements need to be added, please insert what requirements are desired.

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

Progress reports should briefly describe status of pilot projects, including data and safety monitoring, and should notify NIH of serious adverse events and unanticipated problems.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over the threshold. See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75and 2 CFR Part 200 – Award Term and Condition for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: https://www.era.nih.gov/need-help  (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-637-3015

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Rebecca Clark, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-496-1175
Email: rclark@mail.nih.gov

?Joanna Kubler-Kielb, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD))
Telephone: 301-642-4571
Email: kielbj@mail.nih.gov

Melissa Copeland
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD))
Telephone: 240-401-3847
Email: melissa.copeland@nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 and 2 CFR Part 200.